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It’s a personal thing: You say stratified medicine and I say…

The UK Academy of Medical Sciences (AMS) does not do hyperbole.  This is a good thing considering the histrionics that usually accompanies discussion about stratified medicine.

AMS brought out its long-awaited report on stratified medicine on Friday entitled ‘Realising the potential of stratified medicine.’ It’s straight-laced approach to the subject matter means it failed to make any headlines. But given who the AMS is, how these things work, and the strong hand of Sir John Bell (former President of the Academy, Chair of the Office for the Strategic Co-ordination of Health Research) behind it, it is likely to be very influential.

This is a veritable tome, if not textbook report, on current knowledge and issues involved in stratified medicine and well worth making the effort to try and read if you can. Its main thrust is how pricing and regulation are holdings things back in terms of this new knowledge being applied for patient benefit. The case studies and examples are very helpful in grounding one’s perspectives in what has actually happened in the field thus far. I should add that I was involved in many of the AMS events and activities that led up to its publication.

The report has two main recommendations on public involvement and engagement. The first (recommendation 6) is that a consortium of organisations including INVOLVE and others should come together to consider the outcome of the Technology Strategy Board (TSB)funded public dialogue exercise. This exercise is about to begin and I am on the TSB Oversight Group which is overseeing the project.

The second (recommendation 18) is more interesting as it calls for the expansion of the existing UK Stratified Medicine Innovation Platform – led by the TSB – to embrace a public/private partnership of organisations looking at how stratified medicine works in clinical settings but focusing on, among other things, public understanding. The public/private mix will be very important in this latter piece as my impression is that the public sector, commercial sector and patients are often talking at cross-purposes and to different agendas if not priorities.

A key theme of this report and other developments over the past few weeks is the NHS’ state of readiness (or lack of it) to incoporate this fast-developing area of medicine into clinical practice (what you and I receie as patients). Hence the significant investment we are seeing in things like Genomics England (see my blog from two weeks ago), NIHR’s Diagnostic Evidence Co-operatives – one of which is focusing on diagnostics in stratified medicine if I remember rightly, even networks like the new Health Informatics Centres as launched in May.

I heard a quite brilliant presentation on this and other ways in which the UK is ‘gearing up to lead,’ by the Scottish Chief Scientist, Andrew Morris, on Friday. He was speaking at the UK Clinical Research Facilities annual conference. Andrew was also a member of the AMS group that produced the report. It was good to hear him say how important the public involvement piece was for him in conversation before the meeting. I shall include a link to his presentation if I am given a copy.

However, whether we arrive at a simple, plain English term for ‘stratified medicine’ is another matter….

Regulating research – Blakemore/Deer comment pieces + AMRC background

Ahead of next week’s Academy of Medical Sciences (AMS) much anticipated report on medical research regulation I see  The Times and Sunday Times (both paywall) have published pieces this weekend by scientist Professor Colin Blakemore and journalist Brian Deer respectively, offering different perspectives on the issue of regulation.

If you are looking for further background on this issue, a reminder that you can read more about patient views on research regulation in the independent report published by AMRC/INVOLVE on 20th December 2010.  And AMRC’s two written submissions to the Academy’s review can be found on our website.

The Academy’s pages on the review are available here.

Good news on medical research regulation

The Prime Minister, Gordon Brown, and the Business Secretary, Lord Mandelson, paid a visit to the Wellcome Trust this morning and announced a clutch of initiatives including:

  • £250 million investment in 2010/11 for the new world-class medical research centre at St Pancras in London which will bring together research teams to tackle major medical challenges. The new UK Centre for Medical Research and Innovation will be a partnership with Cancer Research UK, the Wellcome Trust, UCL and the Medical Research Council (MRC) and will work closely with the NHS.
  • The appointment, in the next parliament, of the first ever Minister for Life Sciences to report to both the Secretaries of State for Business and Health – should the Labour Party form for the next Government.
  • A doctoral scholarship scheme – Newton Scholarships – to provide support for around 100 of the world’s best research students annually and to sustain the UK’s excellence in research capability.

But medical research charities will be particularly pleased to hear that the Government has set-up an independent review of the regulatory environment for medical and health research stating:

‘Following concern that the process of medical research is being jeopardised by a complex legal and regulatory framework, the Government also today announced an independent review of it. The framework is having a negative impact on the health and wealth of the country. It is affecting both the UK’s competitiveness as a site for industry-funded research and the speed with which advances in basic science can be turned into benefits for patients.

The Government has therefore asked the Academy of Medical Sciences to conduct a rapid independent review of the regulation and governance of medical research. This will be chaired by Sir Michael Rawlins in his capacity as a senior fellow. In view of the particular problems for clinical trials, the review will have a specific focus in this area.’

The problems associated with regulation and bureaucracy have been a regular feature of my posts on this blog and a review sounds like a sensible next step to developing a better regulatory environment.  Some people may remember that it was the Academy’s report into clinical research six years or so ago that led to the establishment of the UK Clinical Research Collaboration, a better infrastructure for clinical trials etc. 

The terms of reference for the review can be found on the Academy’s website.

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